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What Eklira Genuair is:
The active ingredient of Eklira Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators. Bronchodilators relax airways and help keep bronchioles open. Eklira Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into your lungs. This makes it easier for chronic obstructive pulmonary disease (COPD) patients to breathe.
What Eklira Genuair is used for:
Eklira Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious, long-term lung disease characterised by breathing difficulties. Regular use of Eklira Genuair can help you when you have ongoing shortness of breath related to your disease and will help you to minimise the effects of the disease on your everyday life.
Do not use Eklira Genuair:
- if you are allergic to aclidinium bromide or any of the other ingredients of this medicine (listed in section 6).
Take special care with Eklira Genuair:
Talk to your doctor, pharmacist or nurse before using Eklira Genuair:
- if you have had heart problems recently.
- if you see halos around lights or coloured images (glaucoma).
- if you have an enlarged prostate, problems passing urine, or a blockage in your bladder.
Eklira Genuair is indicated for maintenance treatment and should not be used to treat a sudden attack of breathlessness or wheezing. If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse you should contact your doctor for advice as soon as possible.
Dry mouth, which has been observed with medicines like Eklira Genuair, may after using your medicine for a long time, be associated with tooth decay. Therefore, please remember to pay attention to oral hygiene.
Stop taking Eklira Genuair and seek medical help immediately:
- if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm;
Other medicines and Eklira Genuair:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inform your doctor if you have been or are using similar medicines for breathing problems, such as medicines containing tiotropium, ipratropium. Ask your doctor or pharmacist if you are not sure. The use of Eklira Genuair with these medicines is not recommended.
Using Eklira Genuair with food and drink:
You can use Eklira Genuair anytime before or after food or drink.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use Eklira Genuair if you are pregnant or are breast-feeding unless your doctor tells you so.
Children and adolescents
Eklira Genuair is not for use in children or adolescents below 18 years of age.
Driving and using machines
Eklira Genuair may have minor influence on the ability to drive and use machines. This medicine may cause headache, dizziness or blurred vision. If you are affected by any of these side effects do not drive or use machinery until the headache has cleared, the feeling of dizziness has passed and your vision has returned to normal.
Important information about some of the ingrediants of Eklira Genuair:
Eklira Genuair contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- The recommended dose is one inhalation twice a day in the morning and evening.
- The effects of Eklira Genuair last for 12 hours; therefore, you should try to use your Eklira Genuair inhaler at the same time every morning and evening. This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night. It will also help you to remember to use it.
- The recommended dose can be used for elderly patients and for patients with kidney or liver problems. No dose adjustments are necessary.
- COPD is a long-term disease; therefore, it is recommended that Eklira Genuair is used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Route of administration
The medicine is for inhalation use.
Refer to the Instructions for Use for instructions on how to use the Genuair inhaler. If you are not sure of how to use Eklira Genuair, contact your doctor or pharmacist.
You can use Eklira Genuair any time before or after food or drink.
- Instructions for use:
This section contains information on how to use your Genuair inhaler. If you have any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for assistance.
This Instructions for Use is divided into sections:
- Getting started
- Step 1: Prepare your dose
- Step 2: Inhale your medicine
- Additional information
Getting Started
Read this Instructions for Use before you start using the medicine.
Become familiar with the parts of Genuair inhaler.
Before use:
a) Before first use, tear open the sealed bag and remove the inhaler. Throw away the bag.
b) Do not press the green button until you are ready to take a dose.
c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).
STEP 1: Prepare your dose
1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).
1.2 Look at the control window (should be red, Figure C).
1.3 Hold the inhaler horizontally with the mouthpiece facing you and the orange button on top (Figure D).
1.4 Press the green button all the way down to load your dose (Figure E).
When you press the button all the way down, the control window changes from red to green.
Stop and Check:
1.6 Make sure the control window is now green (Figure G).
Your medicine is ready to be inhaled.
Go to ‘STEP 2: Inhale your medicine’.
STEP 2: Inhale your medicine
2.1 Hold the inhaler away from your mouth, and breathe out completely. Never breathe out into the inhaler (Figure I).
2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around it (Figure J).
2.3 Take a strong, deep breath through your mouth. Keep breathing in for as long as possible.
2.4 Take the inhaler out of your mouth.
2.5 Hold your breath for as long as possible.
2.6 Slowly breathe out.
Stop and Check:
2.7 Make sure the control window is now red (Figure K). This means you have inhaled your medicine correctly.
Push the protective cap back onto the mouthpiece after each use (Figure M).
Additional information
What should you do if you accidently prepare a dose?
Store your inhaler with the protective cap in place until it is time to inhale your medicine, then remove the cap and start at Step 1.6.
How does the dose indicator work?
· The dose indicator shows the total number of doses left in the inhaler (Figure N).
· On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
· Each time you load a dose by pressing the green button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
When should you get a new inhaler?
You should get a new inhaler:
· If your inhaler appears to be damaged or if you lose the cap, or
· When a red band appears in the dose indicator, this means you are nearing your last dose (Figure N), or
· If your inhaler is empty (Figure O).
Figure N
How do you know that your inhaler is empty?
When the green button will not return to its full upper position and is locked in a middle position, you have reached the last dose (Figure O). Even though the orange button is locked, your last dose may still be inhaled. After that, the inhaler cannot be used again and you should start using a new inhaler.
Figure O
How should you clean the inhaler?
NEVER use water to clean the inhaler, as this may damage your medicine.
If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper towel.
If you use more Eklira Genuair than you should:
If you think you may have used more Eklira Genuair than you should, contact your doctor or pharmacist.
If you forget to use Eklira Genuair:
If you forget a dose of Eklira Genuair, inhale the dose as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop using Eklira Genuair:
This medicine is for long-term use. If you want to stop treatment, first talk to your doctor, as your symptoms may worsen.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions may rarely occur (may affect up to 1 in 1,000 people). Stop using the medicine and contact your doctor immediately if you develop swelling of your face, throat, lips or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, faster heart rate or if you get raised severely itchy bumps on your skin (hives) as these may be symptoms of an allergic reaction.
The following side effects may occur whilst using Eklira Genuair:
Common: may affect up to 1 in 10 people
- Headache
- Inflammation of the sinuses (sinusitis)
- Common cold (nasopharyngitis)
- Cough
- Diarrhoea
- Nausea
Uncommon: may affect up to 1 in 100 people
- Dizziness
- Dry mouth
- Inflammation of the mouth (stomatitis)
- Hoarseness (dysphonia)
- Faster heart beat (tachycardia)
- Sensation of heart beating (palpitations)
- Difficulty passing urine (urinary retention)
- Blurred vision
- Rash
- Itching of the skin
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the National Pharmacovigilance Center contacts at the end of this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the inhaler label and carton after “EXP”. The expiry date refers to the last day of that month.
Store above 30 °C.
To be used within 90 days of opening the pouch.
Keep the inhaler inside the pouch until the administration period starts.
Do not use the Eklira Genuair if you notice that the pack is damaged or shows signs of tampering.
After you have taken the last dose, the inhaler has to be disposed of. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
- The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms aclidinium bromide equivalent to 322 micrograms of aclidinium.
- The other ingredient is lactose monohydrate (refer to Section 2 “Eklira Genuair contains lactose”).
Marketing Authorisation Holder:
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer:
Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca, Barcelona
Spain
ما هو ايكليرا جينوإير:
المادة الفعالة في ايكليرا جينوإير هي بروميد الأكليدينيوم، والتي تنتمي إلى مجموعة من الأدوية يُطلق عليها اسم الموسِّعات القصبية. تؤدي الموسِّعات القصبية إلى إرخاء المجاري الهوائية وتساعد على الحفاظ على القصيبات مفتوحة. ايكليرا جينوإير عبارة عن جهاز استنشاق مسحوق جاف يستخدم النَفس لتوصيل الدواء مباشرةً إلى الرئتين. يسهّل هذا الأمر عملية التنفس على مرضى الانسداد الرئوِي المزمن (COPD).
دواعي استعمال ايكليرا جينوإير:
يُستعمَل ايكليرا جينوإير للمساعدة على فتح المجاري الهوائية وتخفيف أعراض الانسداد الرئوِي المزمن (COPD)، وهو مرض رئوي خطير وطويل الأجل يتسم بصعوبة التنفس. إن استخدام ايكليرا جينوإير بانتظام يساعدك إذا كنت تعاني من ضيق مستمر في التنفس مرتبط بمرضك، وسيساعدك على تقليل آثار المرض على حياتك اليومية.
لا تستعمل ايكليرا جينوإير:
- إذا كانت لديك حساسية تجاه بروميد الأكليدينيوم أو أي من المكونات الأخرى لهذا الدواء (المذكورة في القسم 6).
توخَّ الحرص الشديد مع ايكليرا جينوإير:
تحدث إلى الطبيب أو الصيدلي أو الممرض قبل استعمال ايكليرا جينوإير:
- إذا كنت تعاني مؤخرًا من مشكلات في القلب.
- إذا كنت ترى هالات حول الأضواء أو الصور الملونة (الزرق).
- إذا كنت تعاني من تضخم في البروستاتا أو مشكلات في التبول أو انسداد في المثانة.
يُوصى باستعمال ايكليرا جينوإير كعلاج مداومة، ويجب عدم استخدامه لعلاج نوبة عُسر التنفس أو الأزيز المفاجئة. إذا لم تتحسن أعراض COPD (عُسر التنفس، الأزيز، السعال) أو ساءت، فيجب عليك الاتصال بالطبيب لاستشارته في أقرب وقت ممكن.
يمكن الربط بين جفاف الفم، الذي لوحِظ مع استخدام أدوية مثل ايكليرا جينوإير، وبين تسوس الأسنان، بعد استخدام الدواء لفترة طويلة. لذا يُرجى تذكر أهمية الحفاظ على صحة الفم والأسنان.
توقف عن تناول ايكليرا جينوإير واطلب المساعدة الطبية فورًا:
- إذا شعرت بضيق في الصدر أو سعال أو أزيز أو عُسر في التنفس مباشرةً بعد استخدام الدواء. قد تكون هذه علامات حالة يُطلق عليه التشنج القصبي؛
الأدوية الأخرى وايكليرا جينوإير:
أخبر طبيبك أو الصيدلي إذا كنت تتناول أو إذا تناولت مؤخرًا أو من الممكن أن تتناول أي أدوية أخرى.
أخبر طبيبك إذا كنت تستخدم أدوية مماثلة لعلاج مشكلات التنفس، مثل الأدوية التي تحتوي على تيوتروبيوم أو إبراتروبيوم. اسأل طبيبك أو الصيدلي إذا لم تكن متأكّدًا. لا يُوصى باستخدام ايكليرا جينوإير مع هذه الأدوية.
استعمال ايكليرا جينوإير مع الطعام والشراب:
يمكنك استخدام ايكليرا جينوإير في أي وقت قبل تناول الطعام أو الشراب أو بعده.
الحمل والرضاعة
إذا كنتِ حاملاً أو ترضعين طبيعيًا أو تعتقدين أنكِ حامل أو تخططين لإنجاب طفل، فاطلبي نصيحة طبيبكِ أو الصيدلي قبل تناول هذا الدواء. يجب عدم استخدام ايكليرا جينوإير إذا كنتِ حاملاً أو تُرضعين طفلكِ رضاعة طبيعية ما لم ينصحكِ الطبيب باستخدامه.
الأطفال والمراهقون
لا يُستخدَم ايكليرا جينوإير مع الأطفال أو المراهقين الذين تقل أعمارهم عن 18 عامًا.
القيادة واستخدام الآلات
ربما يكون لايكليرا جينوإير تأثير طفيف على القدرة على القيادة واستخدام الآلات. قد يسبب هذا الدواء الصداع أو الدُوار أو تشوش الرؤية. إذا تعرضت لأي من هذه الآثار الجانبية، فلا تقود السيارة أو تستعمل الآلات حتى يزول عنك الصداع أو الشعور بالدوار وتعود رؤيتك إلى حالتها الطبيعية.
معلومات مهمة حول بعض مكونات ايكليرا جينوإير:
يحتوي ايكليرا جينوإير على اللاكتوز. إذا أخبرك الطبيب أنك لا تحتمل بعض أنواع السكر، فاتصل بطبيبك قبل تناول هذا الدواء.
تناول دائمًا هذا الدواء بالطريقة التي يصفها لك طبيبك أو الصيدلي بالضبط. استشر طبيبك أو الصيدلي إذا كانت تساورك أيّ شكوك.
- الجرعة الموصى بها هي استنشاق واحد مرتين يوميًا في الصباح والمساء.
- يستمر تأثير ايكليرا جينوإير لمدة 12 ساعة؛ لذا يجب أن تحاول استعمال جهاز استنشاق ايكليرا جينوإير في الوقت نفسه كل صباح ومساء. سيضمن ذلك وجود دواء كافٍ في جسمك دائمًا لمساعدتك على التنفس بسهولة أكبر طوال النهار والليل. كما سيساعدك ذلك على تذكر استخدامه.
- يمكن استخدام الجرعة الموصى بها للمرضى كبار السن والمرضى الذين يعانون من مشكلات في الكلى أو الكبد. ولا يلزم تعديل الجرعة.
- الانسداد الرئوِي المزمن (COPD) هو مرض طويل الأجل؛ لذا يوصى باستخدام ايكليرا جينوإير يوميًا، مرتين في اليوم وليس فقط عند الشعور بمشاكل في التنفس أو الشعور بأعراض أخرى من أعراض الانسداد الرئوِي المزمن.
طريقة التعاطي
هذا الدواء للاستخدام بالاستنشاق.
راجع تعليمات الاستخدام من أجل تعليمات كيفية استخدام جهاز الاستنشاق جينوإير. إذا كنت غير متأكد من كيفية استخدام ايكليرا جينوإير، فاتصل بطبيبك أو الصيدلي.
يمكنك استخدام ايكليرا جينوإير في أي وقتٍ قبل تناول الطعام أو الشراب أو بعده.
- تعليمات الاستخدام:
يحتوي هذا القسم على معلومات عن كيفية استخدام جهاز استنشاق جينوإير. إذا كانت لديك أي أسئلة عن كيفية استخدام جهاز الاستنشاق، فيُرجى استشارة الطبيب، أو الصيدلي، أو الممرضة للحصول على المساعدة.
تنقسم تعليمات الاستخدام هذه إلى أقسام:
- بدء الاستخدام
- الخطوة 1: حضّر الجرعة
- الخطوة 2: استنشق الدواء
- المزيد من المعلومات
بدء الاستخدام
اقرأ تعليمات الاستخدام هذه قبل أن تبدأ في استخدام الدواء.
تعرف على أجزاء جهاز الاستنشاق جينوإير.
قبل الاستخدام:
أ) قبل أول استخدام، افتح الكيس المغلق وأخرج جهاز الاستنشاق. تخلص من الكيس.
ب) لا تضغط على الزر الأخضر إلا عندما تكون مستعدًا لأخذ جرعة
ج) اسحب الغطاء بالضغط بلطف على الأسهم الموجودة على كل جانب (الشكل ب).
الخطوة 1: حضّر الجرعة
1.1 انظر في فتحة الجزء المخصص للفم وتأكد من عدم وجود شيء يسدها (الشكل ج).
1.2 انظر إلى نافذة التحكم (يجب أن تكون حمراء، الشكل ج).
1.3 أمسِك جهاز الاستنشاق في وضع أفقي بحيث يكون الجزء المخصص للفم مواجهًا لك والزر البرتقالي في الأعلى (الشكل د).
1.4 اضغط على الزر الأخضر حتى ينزل لأسفل بالكامل لتحميل الجرعة (الشكل هـ).
عندما تضغط على الزر لينزل بالكامل تتغير نافذة التحكم من الأحمر إلى الأخضر.
توقف وتحقق:
1.6 تأكد من أن نافذة التحكم خضراء الآن (الشكل ز).
دواؤك جاهزاً لاستنشاقه.
انتقل إلى "الخطوة 2: استنشق الدواء".
الخطوة 2: استنشق الدواء
2.1 أمسك بجهاز الاستنشاق بعيدًا عن فمك، وأخرج الزفير كاملاً. لا تُخرج الزفير في جهاز الاستنشاق أبدًا (الشكل ط).
2.2 اجعل رأسك منتصبة، وضع الجزء المخصص للفم بين شفتيك، وأغلق شفتيك حوله بإحكام (الشكل ي).
2.3 خُذ نفسًا قويًا عميقًا من فمك. واصل الشهيق لأطول مدة ممكنة.
2.4 أخرج جهاز الاستنشاق من فمك.
2.5 احبس نفسك لأطول مدة ممكنة.
2.6 أخرج الزفير ببطء.
توقف وتحقق:
2.7 تأكد من أن نافذة التحكم حمراء الآن (الشكل ك). يعني هذا أنك قد استنشقت الدواء بشكل صحيح.
ادفع الغطاء الواقي مرة أخرى داخل الجزء المخصص للفم بعد كل استخدام (الشكل م).
المزيد من المعلومات
ما الذي ينبغي أن تفعله إذا حضرت جرعة عن طريق الخطأ؟
احفظ جهاز الاستنشاق مع وضع الغطاء الواقي في مكانه إلى أن يحين موعد استنشاق الدواء، ثم انزع الغطاء وابدأ من الخطوة 1.6.
كيف يعمل مؤشر الجرعة؟
· يُظهِر مؤشر الجرعة إجمالي عدد الجرعات المتبقية في جهاز الاستنشاق (الشكل ن).
· عند أول استخدام، يحتوي كل جهاز استنشاق على 60 جرعة على الأقل، أو 30 جرعة على الأقل، حسب حجم العبوة.
· في كل مرة تقوم بتحميل جرعة بالضغط على الزر الأخضر، يتحرك مؤشر الجرعة بمقدار ضئيل تجاه الرقم التالي (50 أو 40 أو 30 أو 20 أو 10 أو 0).
متى يجب عليك الحصول على جهاز استنشاق جديد؟
يجب عليك الحصول على جهاز استنشاق جديد:
· إذا ظهر أن جهاز الاستنشاق تالف أو إذا فقدت الغطاء.
· عندما يظهر خط أحمر في مؤشر الجرعة، يعني هذا أنك تقترب من الجرعة الأخيرة (الشكل ن).
· إذا كان جهاز الاستنشاق فارغًا (الشكل س).
كيف تعرف أن جهاز الاستنشاق فارغاً؟
عندما لا يعود الزر الأخضر إلى وضعه العلوي الكامل ويكون محجوزاً في المنتصف، فإنك بهذا تكون قد وصلت إلى الجرعة الأخيرة (الشكل س). حتى على الرغم من أن الزر البرتقالي محجوزاً، لا يزال من الممكن استنشاق الجرعة الأخيرة. وبعد ذلك، لا يمكن استخدام جهاز الاستنشاق مرةً أخرى ويجب البدء في استخدام جهاز استنشاق جديد.
الشكل س
كيف ينبغي أن تنظف جهاز الاستنشاق؟
لا تستخدم الماء "مطلقًا" لتنظيف جهاز الاستنشاق، لأن هذا قد يتسبب في تلف الدواء.
إذا كنت تريد تنظيف جهاز الاستنشاق، فما عليك سوى مسح الجزء الخارجي من الجزء المخصص للفم بمنديل ورقي جاف أو منشفة ورقية جافة.
إذا استعملت جرعة أكبر مما ينبغي من ايكليرا جينوإير:
إذا كنت تعتقد أنك تناولت جرعة زائدة من ايكليرا جينوإير، فاتصل بالطبيب أو الصيدلي.
إذا نسيت استعمال ايكليرا جينوإير:
إذا نسيت تناول جرعة من ايكليرا جينوإير، فتناولها بمجرد أن تتذكر. ولكن إذا اقترب وقت الجرعة التالية، فلا تتناول الجرعة التي نسيتها.
لا تتناول جرعة مزدوجة لتعويض جرعة فائتة.
إذا توقفت عن تناول ايكليرا جينوإير:
هذا الدواء مخصص للاستعمال طويل الأجل. إذا كنت تريد إيقاف العلاج، فتحدث إلى طبيبك أولاً لأن الأعراض التي تشعر بها قد تسوء.
تحدث إلى طبيبك أو الصيدلي أو الممرضة إذا كانت لديك أي أسئلة أخرى حول استعمال هذا الدواء.
شأنه شأن جميع الأدوية، قد يتسبّب هذا الدواء في حدوث آثار جانبية على الرغم من أنها لا تصيب الجميع.
قد تحدث التفاعلات التحسسية بشكل نادر (قد تؤثر على شخص واحد من كل 1000 شخص). توقف عن استخدام هذا الدواء واتصل بالطبيب فورًا إذا ظهرت عليك أعراض مثل التورم في الوجه أو الحلق أو الشفتين أو اللسان (مع أو بدون صعوبة في التنفس أو البلع)، أو دوار أو إغماء، أو سرعة ضربات القلب، أو إذا ظهرت نتوءات تسبب الحكة الشديدة على جلدك (شرى)، فقد تكون هذه أعراض الإصابة بحساسية.
قد تحدث الآثار الجانبية التالية أثناء تناول ايكليرا جينوإير:
الآثار الجانبية الشائعة: قد تؤثر على شخص من كل 10 أشخاص
- الصداع
- التهاب الجيوب الأنفية (التهاب الجيوب)
- الزكام (التهاب البلعوم الأنفي)
- السعال
- الإسهال
- الغثيان
الآثار الجانبية غير الشائعة: قد تؤثر على شخص من كل 100 شخص
- الدوار
- جفاف الفم
- التهاب داخل الفم (التهاب الفم)
- بحة في الصوت (بحة الصوت)
- ضربات قلب أسرع (تسارع دقات القلب)
- الإحساس بضربات القلب (الخفقان)
- صعوبة التبول (احتباس البول)
- عدم وضوح الرؤية
- الطفح الجلدي
- حكة الجلد
الإبلاغ عن الآثار الجانبية
إذا شعرت بأي آثار جانبية، فتحدّث إلى طبيبك أو الصيدلي أو الممرضة. يشمل ذلك أي آثار جانبية محتملة غير مذكورة في هذه النشرة. يمكنك أيضًا الإبلاغ عن الإصابة بالآثار الجانبية مباشرةً من خلال الاتصال بأرقام المركز الوطني للتيقظ والسلامة الدوائية (National Pharmacovigilance Center) الموجودة في نهاية هذه النشرة. بالإبلاغ عن الآثار الجانبية، يمكنك تقديم مزيدٍ من المعلومات عن سلامة هذا الدواء.
احفظ هذا الدواء بعيداً عن مرأى الأطفال ومتناولهم.
لا تستخدم هذا الدواء بعد تاريخ انتهاء صلاحيته المدون على ملصق جهاز الاستنشاق والعلبة الخارجية والموضح بكلمة "EXP". يشير تاريخ انتهاء الصلاحية إلى آخر يوم في الشهر المذكور.
يُحفظ في درجة حرارة أعلى من 30 درجة مئوية.
ينبغي استخدامه خلال 90 يومًا من تاريخ فتح الغلاف.
احتفظ بجهاز الاستنشاق داخل كيسه حتى تبدأ فترة الاستخدام.
لا تستخدم ايكليرا جينوإير إذا لاحظت تلف العبوة أو في حالة ظهور أي علامات عبث عليها.
يجب التخلص من جهاز الاستنشاق بعد تناول الجرعة الأخيرة. لا تتخلص من أي أدوية بإلقائها في مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن إجراءات التخلص من الأدوية التي لم تعد تستعملها. ستساعد هذه الإجراءات على حماية البيئة.
- المادة الفعالة هي بروميد الأكليدينيوم. تتضمن كل جرعة مقدمة 375 ميكروغرامًا من بروميد الأكليدينيوم، أي ما يعادل 322 ميكروغرامًا من الأكليدينيوم.
- المكوّن الآخر هو أحادي هيدرات اللاكتوز (ارجع إلى القسم 2 "يحتوي ايكليرا جينوإير على اللاكتوز").
حامل ترخيص التسويق:
AstraZeneca AB
SE-151 85 Södertälje
Sweden
جهة التصنيع:
Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca, Barcelona
Spain
Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Posology:
The recommended dose is one inhalation of 322 micrograms aclidinium twice daily.
If a dose is missed the next dose should be taken as soon as possible. However, if it is nearly time for the next dose, the missed dose should be skipped.
Elderly:
No dose adjustments are required for elderly patients (see section 5.2).
Renal impairment:
No dose adjustments are required for patients with renal impairment (see section 5.2).
Hepatic impairment:
No dose adjustments are required for patients with hepatic impairment (see section 5.2).
Paediatric population:
There is no relevant use of Eklira Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Method of administration: For inhalation use.
Patients should be instructed on how to administer the product correctly as the Genuair may work differently from inhalers the patients may have used previously. It is important to instruct the patients to read the instructions for use in the Package Leaflet, which is packed together with each inhaler.
For instructions for use, see section 6.6.
Paradoxical bronchospasm:
Administration of Eklira Genuair may cause paradoxical bronchospasm. If this occurs, treatment with Eklira Genuair should be stopped and other treatments considered.
Deterioration of disease:
Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, i.e. as a rescue therapy. In the event of a change in COPD intensity while the patient is being treated with aclidinium bromide so that the patient considers additional rescue medication is required, a re-evaluation of the patient and the patients’ treatment regimen should be conducted.
Cardiovascular effects:
Cardiovascular safety profile is characterized by the anticholinergic effects.
Eklira Genuair should be used with caution in patients who had a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association”. Such patients were excluded from the clinical trials because these conditions may be affected by the anticholinergic mechanism of action.
Anticholinergic activity:
Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
Consistent with its anticholinergic activity, aclidinium bromide should be used with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).
Excipients:
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is not recommended.
Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the therapeutic dose are not expected to cause interactions with active substances that are substrates of P-glycoprotein (P-gp), or active substances metabolised by cytochrome P450 (CYP450) enzymes and esterases (see section 5.2).
Pregnancy:
There are no data available on the use of aclidinium bromide in pregnant women.
Studies in animals have shown fetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3). Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.
Breast-feeding:
It is unknown whether aclidinium bromide/metabolites are excreted in human milk. Animal studies have shown excretion of small amounts of aclidinium bromide/metabolites into milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eklira Genuair therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility:
Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3). It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.
Aclidinium bromide may have minor influence on the ability to drive and use machines. The occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide (see section 4.8) may influence the ability to drive or to use machinery.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
Summary of the safety profile:
The most frequently reported adverse reactions with Eklira Genuair were headache (6.6%) and nasopharyngitis (5.5%).
Tabulated summary of adverse reactions:
The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to Eklira Genuair) observed with Eklira Genuair 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
System organ class | Preferred term | Frequency |
Infections and infestations | Sinusitis | Common |
Nasopharyngitis | Common | |
Immune system disorders | Hypersensitivity | Rare |
Angioedema | Not known | |
Anaphylactic reaction | Not known | |
Nervous system disorders | Headache | Common |
Dizziness | Uncommon | |
Eye disorders | Blurred vision | Uncommon |
Cardiac disorders | Tachycardia | Uncommon |
Palpitations | Uncommon | |
Respiratory, thoracic and mediastinal disorders | Cough | Common |
Dysphonia | Uncommon | |
Gastrointestinal disorders | Diarrhoea | Common |
Nausea* | Common | |
Dry mouth | Uncommon | |
Stomatitis | Uncommon | |
Skin and subcutaneous tissue disorders | Rash | Uncommon |
Pruritus | Uncommon | |
Renal and urinary disorders | Urinary retention | Uncommon |
* The incidence of nausea in clinical trials was lower for aclidinium bromide than for placebo (43.9 vs
48.3 per 1000 patient-years respectively)
High doses of aclidinium bromide may lead to anticholinergic signs and symptoms.
However, single inhaled doses up to 6,000 µg aclidinium bromide have been administered to healthy subjects without systemic anticholinergic adverse reactions. Additionally, no clinically relevant adverse reactions were observed following 7-day twice daily dosing of up to 800 µg aclidinium bromide in healthy subjects.
Acute intoxication by inadvertent medicinal product ingestion of aclidinium bromide is unlikely due to its low oral bioavailability and the breath-actuated dosing mechanism of the Genuair inhaler.
Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics; ATC Code: R03BB05.
Mechanism of action
Aclidinium bromide is a competitive, selective muscarinic receptor antagonist (also known as an anticholinergic), with a longer residence time at the M3 receptors than the M2 receptors. M3 receptors mediate contraction of airway smooth muscle. Inhaled aclidinium bromide acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation. Nonclinical in vitro and in vivo studies showed rapid, dose-dependent and long-lasting inhibition by aclidinium of acetylcholine-induced bronchoconstriction. Aclidinium bromide is quickly broken down in plasma, the level of systemic anticholinergic side effects is therefore low.
Pharmacodynamic effects:
Clinical efficacy studies showed that Eklira Genuair provided clinically meaningful improvements in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours following morning and evening administration, which were evident within 30 minutes of the first dose (increases from baseline of 124-133 mL). Maximal bronchodilation was achieved within 1-3 hours after dosing with mean peak improvements in FEV1 relative to baseline of 227-268 mL at steady- state.
Cardiac electrophysiology:
No effects on QT interval (corrected using either the Fridericia or Bazett method or individually- corrected) were observed when aclidinium bromide (200 µg or 800 µg) was administered once daily for 3 days to healthy subjects in a thorough QT study.
In addition, no clinically significant effects of Eklira Genuair on cardiac rhythm were observed on 24-hour Holter monitoring after 3 months treatment of 336 patients (of whom 164 received Eklira Genuair 322 µg twice daily).
Clinical efficacy and safety:
The Eklira Genuair Phase III clinical development programme included 269 patients treated with Eklira Genuair 322 µg twice daily in one 6-month randomised, placebo-controlled study and
190 patients treated with Eklira Genuair 322 µg twice daily in one 3-month randomised, placebo- controlled study. Efficacy was assessed by measures of lung function and symptomatic outcomes such as breathlessness, disease-specific health status, use of rescue medication and occurrence of exacerbations. In the long-term safety studies, Eklira Genuair was associated with bronchodilatory efficacy when administered over a 1-year treatment period.
Bronchodilation:
In the 6-month study, patients receiving Eklira Genuair 322 µg twice daily experienced a clinically meaningful improvement in their lung function (as measured by FEV1). Maximal bronchodilatory effects were evident from day one and were maintained over the 6-month treatment period. After
6 months treatment, the mean improvement in morning pre-dose (trough) FEV1 compared to placebo was 128 mL (95% CI=85-170; p<0.0001).
Similar observations were made with Eklira Genuair in the 3 month study.
Disease-Specific Health Status and Symptomatic Benefits:
Eklira Genuair provided clinically meaningful improvements in breathlessness (assessed using the Transition Dyspnoea Index [TDI]) and disease-specific health status (assessed using the St. George’s Respiratory Questionnaire [SGRQ]). The Table below shows symptom relief obtained after 6 months treatment with Eklira Genuair.
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Variable | Treatment | Improvement over placebo | p-value | |
Eklira Genuair | Placebo | |||
TDI | ||||
Percentage of Patients who achieved MCIDa | 56.9 | 45.5 | 1.68-foldc increase in likelihood | 0.004 |
Mean Change from baseline | 1.9 | 0.9 | 1.0 unit | <0.001 |
SGRQ | ||||
Percentage of Patients who achieved MCIDb | 57.3 | 41.0 | 1.87-foldc increase in likelihood | <0.001 |
Mean Change from baseline | -7.4 | -2.8 | - 4.6 units | <0.0001 |
a Minimum clinically important difference (MCID) of at least 1 unit change in TDI. b MCID of at least - 4 units change in SGRQ.
c Odds ratio, increase in the likelihood of achieving the MCID compared to placebo.
Patients treated with Eklira Genuair required less rescue medication than patients treated with placebo (a reduction of 0.95 puffs per day at 6 months [p=0.005]). Eklira Genuair also improved daily symptoms of COPD (dyspnoea, cough and sputum production) and night-time and early morning symptoms.
Pooled efficacy analysis of the 6-month and 3-month placebo controlled studies demonstrated a statistically significant reduction in the rate of moderate to severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with aclidinium 322 µg twice daily compared to placebo (rate per patient per year: 0.31 vs 0.44 respectively; p=0.0149).
Exercise tolerance:
In a 3-week crossover, randomised, placebo-controlled clinical study Eklira Genuair was associated with a statistically significant improvement in exercise endurance time in comparison to placebo of 58 seconds (95% CI=9-108; p=0.021; pre-treatment value: 486 seconds). Eklira Genuair statistically significantly reduced lung hyperinflation at rest (functional residual capacity [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; residual volume [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) and also
improved trough inspiratory capacity (by 0.078 L; 95% CI=0.01, 0.145; p=0.025) and reduced dyspnoea during exercise (Borg scale) (by 0.63 Borg units; 95% CI=1.11, 0.14; p=0.012).
Paediatric population:
The European Medicines Agency has waived the obligation to submit the results of studies with Eklira Genuair in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Absorption:
Aclidinium bromide is rapidly absorbed from the lung, achieving maximum plasma concentrations within 5 minutes of inhalation in healthy subjects, and normally within the first 15 minutes in COPD patients. The fraction of the inhaled dose that reaches the systemic circulation as unchanged aclidinium is very low at less than 5%.
Steady state peak plasma concentrations achieved after dry powder inhalation by COPD patients of 400 µg aclidinium bromide were approximately 224 pg/mL. Steady-state plasma levels were attained within seven days of twice daily dosing.
Distribution:
Whole lung deposition of inhaled aclidinium bromide via the Genuair inhaler averaged approximately 30% of the metered dose.
The plasma protein binding of aclidinium bromide determined in vitro most likely corresponded to the protein binding of the metabolites due to the rapid hydrolysis of aclidinium bromide in plasma;
plasma protein binding was 87% for the carboxylic acid metabolite and 15% for the alcohol metabolite. The main plasma protein that binds aclidinium bromide is albumin.
Biotransformation:
Aclidinium bromide is rapidly and extensively hydrolysed to its pharmacologically inactive alcohol- and carboxylic acid-derivatives. The hydrolysis occurs both chemically (non-enzymatically) and enzymatically by esterases, butyrylcholinesterase being the main human esterase involved in the hydrolysis. Plasma levels of the acid metabolite are approximately 100-fold greater than those of the alcohol metabolite and the unchanged active substance following inhalation.
The low absolute bioavailability of inhaled aclidinium bromide (<5%) is because aclidinium bromide undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or swallowed.
Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium bromide.
In vitro studies have shown that aclidinium bromide at the therapeutic dose or its metabolites do not inhibit or induce any of the cytochrome P450 (CYP450) enzymes and do not inhibit esterases (carboxylesterase, acetylcholinesterase and butyrylcholinesterase). In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide are not substrates or inhibitors of
P-glycoprotein.
Elimination:
The terminal elimination half-life and effective half-life of aclidinium bromide are approximately 14 hours and 10 hours, respectively, following inhalation of twice daily 400 µg doses in COPD patients.
Following intravenous administration of 400 µg radiolabelled aclidinium bromide to healthy subjects, approximately 1% of the dose was excreted as unchanged aclidinium bromide in the urine. Up to 65% of the dose was eliminated as metabolites in the urine and up to 33% as metabolites in the faeces.
Following inhalation of 200 µg and 400 µg of aclidinium bromide by healthy subjects or COPD patients, the urinary excretion of unchanged aclidinium was very low at about 0.1% of the administered dose, indicating that renal clearance plays a minor role in the total aclidinium clearance from plasma.
Linearity/non-linearity:
Aclidinium bromide demonstrated kinetic linearity and a time-independent pharmacokinetic behaviour in the therapeutic range.
Special populations:
Elderly patients:
The pharmacokinetic properties of aclidinium bromide in patients with moderate to severe COPD appear to be similar in patients aged 40–59 years and in patients aged ≥70 years. Therefore, no dose adjustment is required for elderly COPD patients.
Hepatically-impaired patients:
No studies have been performed on hepatically-impaired patients. As aclidinium bromide is metabolised mainly by chemical and enzymatic cleavage in the plasma, hepatic dysfunction is very unlikely to alter its systemic exposure. No dose adjustment is required for hepatically- impaired COPD patients.
Renally-impaired patients:
No significant pharmacokinetic differences were observed between subjects with normal renal function and subjects with renal impairment. Therefore, no dose adjustment and no additional monitoring are required for renally-impaired COPD patients.
Race
Following repeated inhalations, the systemic exposure of aclidinium bromide has been observed to be similar in Japanese and Caucasian patients
Pharmacokinetic/pharmacodynamic relationship
Because aclidinium bromide acts locally in the lungs and is quickly broken down in plasma there is no direct relationship between pharmacokinetics and pharmacodynamics.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential, toxicity to reproduction and development.
Effects in nonclinical studies with respect to cardiovascular parameters (increased heart rates in dogs), reproductive toxicity (fetotoxic effects), and fertility (slight decreases in conception rate, number of corpora lutea, and pre- and post-implantation losses) were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
The low toxicity observed in nonclinical toxicity studies is in part due to rapid metabolism of aclidinium bromide in plasma and the lack of significant pharmacological activity of the major metabolites. The safety margins for human systemic exposure with 400 µg twice daily over the no observed adverse effect levels in these studies ranged from 7- to 73-fold.
Lactose monohydrate.
Not applicable.
Do not store above 30 °C.
Keep the inhaler inside the pouch until the administration period starts.
The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene- styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel. It is white-coloured with an integral dose indicator and a green dosage button. The mouthpiece is covered with a removable green protective cap. The inhaler is supplied in a plastic laminate pouch, placed in a cardboard carton.
Carton containing 1 inhaler with 60 doses.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instructions for Use
Getting Started
Read this Instructions for Use before you start using the medicine.
Become familiar with the parts of Genuair inhaler.
Figure A
Before use:
a) Before first use, tear open the sealed bag and remove the inhaler. Throw away the bag.
b) Do not press the green button until you are ready to take a dose.
c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).
STEP 1: Prepare your dose
1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).
1.2 Look at the control window (should be red, Figure C).
1.3 Hold the inhaler horizontally with the mouthpiece facing you and the green button on top (Figure D).
1.4 Press the green button all the way down to load your dose (Figure E).
When you press the button all the way down, the control window changes from red to green.
Stop and Check:
1.6 Make sure the control window is now green (Figure G).
Your medicine is ready to be inhaled.
Go to ‘STEP 2: Inhale your medicine’.
STEP 2: Inhale your medicine
2.1 Hold the inhaler away from your mouth, and breathe out completely. Never breathe out into the inhaler (Figure I).
2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around it (Figure J).
2.3 Take a strong, deep breath through your mouth. Keep breathing in for as long as possible.
2.4 Take the inhaler out of your mouth.
2.5 Hold your breath for as long as possible.
2.6 Slowly breathe out.
Stop and Check:
2.7 Make sure the control window is now red (Figure K). This means you have inhaled your medicine correctly.
Push the cap back onto the mouthpiece after each use (Figure M).
Additional information
What should you do if you accidently prepare a dose?
Store your inhaler with the protective cap in place until it is time to inhale your medicine, then remove the cap and start at Step 1.6.
How does the dose indicator work?
· The dose indicator shows the total number of doses left in the inhaler (Figure N).
· On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
· Each time you load a dose by pressing the green button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
When should you get a new inhaler?
You should get a new inhaler:
· If your inhaler appears to be damaged or if you lose the cap, or
· When a red band appears in the dose indicator, this means you are nearing your last dose (Figure N), or
· If your inhaler is empty (Figure O).
How do you know that your inhaler is empty?
When the orange button will not return to its full upper position and is locked in a middle position, you have reached the last dose (Figure O). Even though the green button is locked, your last dose may still be inhaled. After that, the inhaler cannot be used again and you should start using a new inhaler.
How should you clean the inhaler?
NEVER use water to clean the inhaler, as this may damage your medicine.
If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper towel.